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New diagnostic test distinguishes bacterial from viral infections

Israeli company MeMed has a rapid diagnostic kit for bacterial infections that could help revolutionize the fight against drug-resistant bacteria.

By Abigail Klein Leichman OCTOBER 9, 2016, 7:00 AM

An Israeli startup is taking aim at a mega global health crisis: overuse of antibiotic drugs.

Haifa-based MeMed, founded in 2009, has won tens of millions in investments and prizes to advance two initial products: ImmunoXpert, now used by hospitals in the EU, Switzerland and Israel to determine rapidly whether an infection is bacterial or viral; and ImmunoPoC, a point-of-care version not yet on the market.

Because they are usually unable to determine the cause of infection, many physicians prescribe antibiotics to be on the safe side. Experts believe that up to 50 percent of antibiotic drug regimens are unnecessary or inappropriate. And antibiotic overuse is a major trigger for drug-resistant strains estimated to kill approximately 50,000 people each year in Europe and the United States.

ImmunoXpert interprets chemical signals from the body’s own immune system to distinguish with over 90 percent accuracy between bacterial and viral infections, empowering physicians to make more informed decisions.

The Israeli assay has been validated in clinical studies involving thousands of patients worldwide. Further multi-center validation trials are ongoing.

Reading the immune system

MeMed CEO Eran Eden was a PhD student at the Weizmann Institute of Science when he started discussing the problem of antibiotic overuse with former classmate Kfir Oved, then a medical student at the Technion-Israel Institute of Technology.

They initially sat at Oved’s grandmother’s kitchen table in Ramat Gan to consider how to overcome the shortcomings of current diagnostic methods.

“There are cultures that require days, and there are rapid tests for infections such as strep throat that require access to the infection site. That’s not always possible, for example with respiratory-tract infections like pneumonia,” Eden tells ISRAEL21c. He notes that respiratory infections in children account for almost half of all doctor visits and hospitalizations.

Even when a microorganism can be identified, nobody knows if it really caused the infection or was simply part of the body’s natural flora.

“We realized that other players have been working on overcoming these challenges for many years, and we were just two guys in a kitchen,” says Eden. “We had to find an advantage; a different angle.”

Instead of trying to access and isolate the pathogen, ImmunoXpert’s sophisticated biosensors and algorithms decode the immune system’s distinct responses to bacterial and viral infections. The kit can also tell if the symptoms aren’t caused by an infection at all.

Results are ready within 99 minutes (the second-generation version will cut this amount to 15 minutes), even for inaccessible infections. The test isn’t confused by harmless bacteria that have not activated the immune system. And there’s no need to adjust the technology to new epidemics, as existing diagnostic methods must do, since the immune system does that naturally.

Millions in investments and prizes

“The few trillion-dollar problem of antibiotic overuse, which give rise to resistant bacteria, requires more than one solution and we can be part of it,” states Eden.

After initially dismissing the MeMed project as impossible, investors and medical experts seem to agree.

MeMed has raised an undisclosed amount from blue-chip VCs ranging from Social+Capital in Silicon Valley to China-based Horizon Ventures. It has received large prizes and grants from entities including the European Commission, which recently awarded €2.3 million to an international consortium coordinating the deployment of ImmunoXpert in Europe. That was on top of a €3 million prize from a June 2015 biotech startup competition in Europe, and a €6 million grant for developing and validating the host-signature underlying ImmunoXpert.

MeMed CEO Eran Eden speaking at the SME Instrument grant program finals in 2015. Next to him are Israeli Chief Scientist Avi Hasson, right, and Lars Faaborg-Andersen, EU ambassador to Israel. Photo courtesy of ISERD PR

MeMed is directing a big chunk of prize money toward clinical studies in Europe, each involving thousands of patients, to further validate ImmunoXpert’s accuracy with different ages and different types of infections.

“It took us six years to build the scientific and regulatory backbone of the product and now a lot of clinical settings want to apply it,” says Eden. “We’ve been approached by a lot of nonprofit and profit organizations, and we have some interesting collaborations to help us come to the American market.”

After the European, Asian and US markets, MeMed looks to expand into Latin America, starting with Brazil. “Bacteria don’t respect borders, and we want to reach as many places as possible,” says Eden.

Oved, the CTO, tells ISRAEL21c that MeMed is a few years ahead of competitors. “We’re well positioned in this arena but we’re a humble company and we always try to see what others are doing to learn from them. The best way for us is to build a great tool with massive evidence behind it.”

The company’s multidisciplinary team includes a staff of 30 in Israel in addition to freelancers in Boston and Washington. Assembly, quality assurance and documentation for ImmunoXpert kits are done in MeMed’s Haifa lab.

“Our second-generation ImmunoPoC device is managed by MeMed’s team in Israel in collaboration with stakeholders around the world,” says Oved. “It involves plastics, electronics and software, so we built a multidisciplinary, multinational team of top-tier companies to assist us with getting this product to market.”

Additional MeMed tools are planned in the future. “We’ve created unique knowhow on the clinical side and molecular and bioinformatics side. Now we can apply it in other ways to better manage diseases mediated by the immune response,” Eden says.